EPA, FDA & USDA Plan for Biotechnology Regulatory Reform

Agencies offer joint plan to clarify and harmonize interagency roles and streamline review processes and paths to commercialization

The biotechnology landscape has evolved rapidly over the past few decades, including significant advancements involving microbes. Executive Order 14081 was issued by President Biden in September 2022 with the goal of accelerating biotechnology innovation and growing America's bioeconomy across multiple sectors, including health, agriculture, and energy. In response to this executive order, the U.S. Environmental Protection Agency, U.S. Food and Drug Administration, and U.S. Department of Agriculture released a joint plan in May 2024 called the Coordinated Framework for the Regulation of Biotechnology, updating their guidelines for biotechnology products to identify "regulatory ambiguities, gaps, or uncertainties" and provide a roadmap for further regulatory reform, including timelines and processes.

The public comment period on the proposed framework is open now through Sept. 3 at: https://www.federalregister.gov/documents/2024/07/02/2024-14498/exploring-pathways-to-commercialization-for-modified-microbes.

Background on the Coordinated Framework for the Regulation of Biotechnology

Advances in science and technology have continued to alter the biotechnology landscape since the release of the 1986 Coordinated Framework from the federal Office of Science & Technology and associated 1992 update. In 2015, the Executive Office of the President issued a memorandum directing EPA, FDA, and USDA to update the Coordinated Framework to facilitate appropriate federal oversight of biotechnology products and increase transparency, while continuing to provide a framework for advancing innovation. The federal government subsequently published a National Strategy for Modernizing the Regulatory System for Biotechnology in 2016 and an Update to the Coordinated Framework in 2017.

New areas of focus, compliance

In their joint plan, EPA, FDA, and USDA have identified five areas of biotechnology product regulation where these actions will focus: modified plants; modified animals; modified microorganism; human drugs, biologics, and medical devices; and cross-cutting issues. Across all areas, the agencies intend to streamline review processes, harmonize cross-agency overlap, and update guidance.

Regarding modified microorganisms (including microbial inoculants and biostimulants used to promote plant growth, microbial biocontrol organisms, plant pests, and microbial biomass associated with human and animal feed), the agencies intend to do the following to limit stakeholder confusion and conflicting regulatory requirements:

1. EPA and USDA will clarify and, when possible, harmonize regulatory roles and processes and data and authorization requirements for the environmental release of modified microbes through increased interagency communication, especially for small-scale field trials.
2. USDA will, through a regularly updated list of taxa on its website (and in coordination with subject matter experts), identify modified microorganisms subject to its regulatory authority and permitting requirements.
3. USDA will explore regulatory changes to exempt "modified biological control organisms that are not plant pests" in certain circumstances, minimizing duplicative regulation of microorganisms with EPA.
4. USDA will pursue regulatory paths to commercialization, including risk-based deregulation, for non-plant organisms subject to their regulatory framework.
5. USDA will implement efficiencies to its permitting process and update user guides to meet its protection goals, ensure efficient movement of modified microorganisms, and harmonize data requirements for modified and non-modified microbes subject to Plant Protection Act regulations.
6. EPA will prioritize biopesticide application review, providing technical assistance to biopesticide developers and collaborating with state pesticide agencies to reduce the time to market for new and effective biopesticides in accord with the Pesticide Registration Improvement Act (PRIA 5).

Future outlook

EPA, FDA, and USDA intend for future updates to the Coordinated Framework to enhance regulatory clarity and improve approval processes while ensuring safety and ethical standards. Industry stakeholders should monitor agency developments for forthcoming draft guidance regarding these joint plans and prepare to offer feedback in the public comment process when made available.

A clearer regulatory landscape will provide a greater degree of certainty as to compliance requirements, ultimately reducing ambiguity and potential legal risks for industry stakeholders. While biotechnology organizations can expect streamlined approval processes in the coming years, expediting the time it takes to bring their products to market, the process of navigating complex regulatory challenges benefits from early consultation with scientific and regulatory experts able to leverage past insights and forecast industry impacts from emerging developments.

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